3rd Feb 2021 09:01
(Alliance News) - 4D Pharma PLC on Wednesday announced enrolment is progressing well both for part B of the MRx0518 and Keytruda combination study and for its pancreatic cancer study.
Single strain live biotherapeutic candidate MRx0518, in development for cancer treatment, is in an ongoing phase one/two clinical trial in combination with immune checkpoint inhibitor Keytruda.
The Leeds, England-based pharmaceutical company said 24 additional patients across five active US sites have been treated in part B of the study, consisting of 12 patients with renal cell carcinoma, 9 patients with non-small cell lung cancer, and 3 bladder cancer patients.
Recruitment will continue up to a total of 30 patients in each of these indications, and enrolment for the trial is expected to complete in the fourth quarter of 2021, 4d Pharma added.
A total of five patients are enrolled in the phase one MRx0518 with radiation in pancreatic cancer trial. This is designed to "evaluate safety and efficacy in 15 patients receiving treatment with MRx0518 and hypofractionated radiation prior to surgery for pancreatic cancer", 4d Pharma said.
"4D pharma has continued to make excellent progress with the MRx0518 development program on multiple fronts. We have generated additional safety and efficacy data, building on the positive data from both the monotherapy and Keytruda combination studies last year. This clinical and development progress has been achieved in spite of the headwinds of Covid-19," said Chief Scientific Officer Alex Stevenson.
"We look forward to generating more clinical data from our ongoing studies of MRx0518 in multiple different tumour types and treatment settings. This will support 4D pharma's continued productive engagement with regulatory authorities to develop the clinical strategy to bring this novel therapeutic to patients suffering from a range of cancers," Stevenson added.
Shares in 4D Pharma were up 4.3% at 120.50 pence in London on Wednesday.
By Zoe Wickens; [email protected]
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